NDC 73250-105 Elixicure All Natural Lavender

Menthol, Camphor

NDC Product Code 73250-105

NDC 73250-105-01

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 30 mL in 1 BOTTLE, WITH APPLICATOR

NDC 73250-105-02

Package Description: 1 BOTTLE, PUMP in 1 BOX > 60 mL in 1 BOTTLE, PUMP

NDC Product Information

Elixicure All Natural Lavender with NDC 73250-105 is a a human over the counter drug product labeled by Honest Globe Inc. The generic name of Elixicure All Natural Lavender is menthol, camphor. The product's dosage form is cream and is administered via topical form.

Labeler Name: Honest Globe Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Elixicure All Natural Lavender Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR, (-)- 30 mg/mL
  • MENTHOL, UNSPECIFIED FORM 70 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Honest Globe Inc
Labeler Code: 73250
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-02-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Elixicure All Natural Lavender Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Menthol 7%Camphor 3%

Purpose

Topical AnalgesicTopical Analgesic

Uses

Temporarily relieves minor aches and pains associated with: Sore Muscles and Joints, Strains, Bruises, Sprains, Aches, and Arthritis.

Warnings

For External Use Only

Do Not Use

On wounds or damaged skinWith a heating padBefore hot shower or apply hot water after application of creamIf you are allergic to any of the listed ingredientsOn irritated skin, otherwise than as directed

When Using This Product

Avoid contact with the eyes and mucous membranesDo not bandage tightly

Stop Use And Ask A Doctor If

Condition worsensSymptoms last more than 7 daysCondition clears up and occurs again with a few daysA rash or irritation developsIf you are experiencing any adverse effects

If Pregnant Or Breastfeeding

As a health professional before use

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Shake well before using

Adults and children 12 years or older: apply to affected area not more than 3-4 times a day

Children under age 12: Consult a physician

Storage And Handling

Keep away from sources of heat and sunlight. Store between 15-25C (60-77F)

Inactive Ingredients

Purified Water, Organic Coconut Oil, Organic Sunflower Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Organic Shea Butter, Xanthan Gum, Apricot Kernel Oil, Phenoxyethanol, Organic Aloe Vera Juice, Citric Acid, Tocopherol, Lactic Acid, Benzoic Acid, Dehydroacetic Acid, Wintergreen Extract, Willow Bark Extract, Tara Seed Extract, Hemp Extract (Cannabidiol)

Questions?

Customerservice@elixicure.com or (714)884-3117

* Please review the disclaimer below.